Browse Device Recalls
1,550 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,550 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 1,550 FDA device recalls in 2012.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 30, 2012 | Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system | Siemens has discovered a possible hazard to patients or hospital personnel when tilting the Urosk... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 29, 2012 | Ultra PC% Cabinet Mount Package G, Model #36600, Serial # 13593, 13594, 135... | Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas wit... | Class I | Accutron Inc |
| Apr 29, 2012 | Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606... | Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas wit... | Class I | Accutron Inc |
| Apr 29, 2012 | CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Consc... | Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas wit... | Class I | Accutron Inc |
| Apr 29, 2012 | Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. ... | Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas wit... | Class I | Accutron Inc |
| Apr 27, 2012 | Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly... | A defect of the "fuse holder" can lead to a Control Unit failure that may cause the device to los... | Class II | Kimberly-Clark Corporation |
| Apr 27, 2012 | PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surger... | Potential failure in the glued seal between the stem and the tip of the handpiece leading to the ... | Class II | Plasma Surgical Inc. |
| Apr 27, 2012 | Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products | It was discovered the CS3000/CS3070 was manufactured using the laser power settings for a Class ... | Class II | Motorola Inc |
| Apr 27, 2012 | Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy ... | The specified Trilogy units are being recalled because of the potential for a faulty component in... | Class I | Respironics, Inc. |
| Apr 27, 2012 | Patient Side Cart Battery Box used in conjunction with the da Vinci A surgica... | Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging. | Class II | Intuitive Surgical, Inc. |
| Apr 26, 2012 | Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich D... | Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable ... | Class II | MicroAire Surgical Instruments, LLC |
| Apr 25, 2012 | The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDA... | The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a "Ster... | Class II | Stryker Spine |
| Apr 24, 2012 | The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic br... | The firm initiated the recall as a result of a misidentification of the brackets. Damon 3MX Bicus... | Class III | Ormco/Sybronendo |
| Apr 23, 2012 | LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spin... | Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from... | Class II | Stryker Spine |
| Apr 23, 2012 | GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Produ... | GE Healthcare has recently become aware of a potential issue due to image flip in frequency encod... | Class II | GE Healthcare, LLC |
| Apr 23, 2012 | SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. P... | Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIG... | Class III | Sigma |
| Apr 23, 2012 | Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqM... | When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK softw... | Class II | Roche Molecular Systems, Inc. |
| Apr 20, 2012 | Grafton DBM Orthoblend Small Defect Multiple Sizes Grafton is a human bon... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft produ... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Optimum Expanse R Grafton is a human bone allograft product containing dem... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Gel Multiple Sizes Grafton is a human bone allograft product ... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft product... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Optimum Expanse S Multiple sizes Grafton is a human bone allograft produc... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bo... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Matrix PLF Multiple Sizes Grafton is a human bone allograft p... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft produ... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Matrix Strips Multiple Sizes Grafton is a human bone allograf... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft produc... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 20, 2012 | Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bo... | Multiple lots of GRAFTON ¿ and XPANSE ¿, which are used for bone grafting procedures are being r... | Class II | Osteotech Inc |
| Apr 19, 2012 | ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled ele... | Potential failure of the optical distance sensor due to cable disconnection. | Class II | Zimmer Biomet, Inc. |
| Apr 19, 2012 | The GE Centricity Web; Software Version 3.0x, is intended for use under the d... | GE Healthcare has become aware of an issue associated with rejected images using the WADO protoco... | Class II | Ge Healthcare It |
| Apr 18, 2012 | Medrad(R) Continuum MR Infusion System Secondary Set Peristaltic Pump Syst... | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... | Class II | Medrad Inc |
| Apr 18, 2012 | Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for ... | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... | Class II | Medrad Inc |
| Apr 18, 2012 | Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristalti... | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... | Class II | Medrad Inc |
| Apr 18, 2012 | Medrad(R) Continuum MR Infusion System Standard Administration Kit Perista... | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... | Class II | Medrad Inc |
| Apr 18, 2012 | Medrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System... | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... | Class II | Medrad Inc |
| Apr 18, 2012 | Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty... | Expired product was shipped to two customers. | Class II | Bacterin International, Inc. |
| Apr 18, 2012 | Medrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump ... | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... | Class II | Medrad Inc |
| Apr 18, 2012 | Medrad(R) Continuum MR Infusion System Primary VSA Set Peristaltic Pump Sy... | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... | Class II | Medrad Inc |
| Apr 18, 2012 | Medrad(R) Continuum MR Infusion System Secondary VSA Set Peristaltic Pump ... | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... | Class II | Medrad Inc |
| Apr 18, 2012 | Medrad(R) Continuum MR Infusion System Side Step Set Peristaltic Pump Syst... | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... | Class II | Medrad Inc |
| Apr 18, 2012 | Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pum... | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... | Class II | Medrad Inc |
| Apr 18, 2012 | Medrad(R) Continuum MR Infusion System Secondary Administration Kit Perist... | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore a... | Class II | Medrad Inc |
| Apr 17, 2012 | High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV. | The firm initiated the recall due to a molding defect in a high pressure stopcock where a small ... | Class II | ICU Medical, Inc. |
| Apr 17, 2012 | Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid A... | The firm initiated the recall due to a molding defect in a high pressure stopcock where a small ... | Class II | ICU Medical, Inc. |
| Apr 17, 2012 | 94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rota... | The firm initiated the recall due to a molding defect in a high pressure stopcock where a small ... | Class II | ICU Medical, Inc. |
| Apr 17, 2012 | Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit | The firm initiated the recall due to a molding defect in a high pressure stopcock where a small ... | Class II | ICU Medical, Inc. |
| Apr 16, 2012 | OPERON D850 Surgical Table Product Usage: Surgical Table | Table was not lowering. | Class II | Berchtold Corp. |
| Apr 16, 2012 | Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs... | The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wh... | Class II | Invacare Corporation |
| Apr 13, 2012 | Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Ver... | As a result of a small number of customer complaints, MAQUET conducted an investigation and ident... | Class II | Maquet Medical Systems, Usa |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.